VALBENAZINE TOSYLATE - Generic Drug Details

What are the generic drug sources for valbenazine tosylate and what is the scope of patent protection?

Valbenazine tosylate is the generic ingredient in three branded drugs marketed by Neurocrine, Lupin Ltd, and Zydus, and is included in four NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Valbenazine tosylate has two hundred and fourteen patent family members in thirty-four countries.

One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for VALBENAZINE TOSYLATE

International Patents:	214
US Patents:	22
Tradenames:	3
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	38
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALBENAZINE TOSYLATE
DailyMed Link:	VALBENAZINE TOSYLATE at DailyMed

Generic filers with tentative approvals for VALBENAZINE TOSYLATE

Applicant	Application No.	Strength	Dosage Form
		80MG	CAPSULE;ORAL
		40MG	CAPSULE;ORAL
		EQ 60MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for VALBENAZINE TOSYLATE

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VALBENAZINE TOSYLATE

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for VALBENAZINE TOSYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INGREZZA	Capsules	valbenazine tosylate	60 mg	209241	1	2022-02-14
INGREZZA	Capsules	valbenazine tosylate	40 mg and 80 mg	209241	4	2021-04-12

US Patents and Regulatory Information for VALBENAZINE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes	11,026,939		Y
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes	11,026,931
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No	10,844,058		Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-002	Apr 30, 2024		RX	Yes	No	10,906,902		Y	Y
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No	10,906,902		Y	Y

International Patents for VALBENAZINE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Israel	284874	מלחי ולבנאזין ופולימורפים שלהם (Valbenazine salts and polymorphs thereof)
Morocco	43116	DITOSYLATE DE VALBÉNAZINE ET POLYMORPHES ASSOCIÉS
Argentina	112819	FORMULACIÓN Y COMPOSICIONES DE VALBENAZINA DE ALTA DOSIS, MÉTODOS Y EQUIPOS RELACIONADOS
China	108473489
Serbia	65154	SOLI VALBENAZIN DIHIDROHLORIDA I NJIHOVI POLIMORFI (VALBENAZINE DIHYDROCHLORIDE SALTS AND POLYMORPHS THEREOF)

VALBENAZINE TOSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Valbenazine Tosylate (INGREZZA)

Introduction

Valbenazine tosylate, marketed under the brand name INGREZZA, is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of tardive dyskinesia and chorea associated with Huntington's disease. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism and Therapeutic Areas

Valbenazine tosylate works by inhibiting the VMAT2, a protein responsible for the transport of monoamines (such as dopamine, serotonin, and norepinephrine) into synaptic vesicles. This mechanism is crucial in managing the symptoms of tardive dyskinesia and Huntington's disease chorea[1].

Market Growth and Demand

The market for INGREZZA has shown significant growth driven by strong underlying patient demand and improvements in gross-to-net dynamics. In the second quarter of 2024, INGREZZA net product sales reached $580 million, representing a 32% year-over-year growth[2].

Year-Over-Year Growth

The drug has consistently demonstrated robust year-over-year growth. For instance, in the third quarter of 2024, INGREZZA net product sales were $613 million, marking a 26% year-over-year increase. This trend is expected to continue, with full-year 2024 net product sales guidance raised to $2.1-$2.2 billion[5].

Financial Highlights

Revenue and Sales

INGREZZA's financial performance has been impressive, with net product sales of $1.84 billion in 2023, representing a 29% year-over-year growth. The total revenues for the third quarter of 2024 were $622.1 million, up from $498.8 million in the same period of 2023[3][5].

Operating Expenses

The increased revenue is accompanied by rising operating expenses, primarily driven by research and development (R&D) and selling, general, and administrative (SG&A) costs. R&D expenses have increased due to investments in muscarinic compounds, gene therapy programs, and second-generation VMAT2 inhibitors. SG&A expenses have also risen due to expanded commercial initiatives and pre-launch activities for other products[2][5].

Net Income and Earnings Per Share

Despite the increase in operating expenses, Neurocrine Biosciences has reported significant net income and earnings per share. For the third quarter of 2024, GAAP net income was $129.8 million, and earnings per share were $1.23, compared to $83.1 million and $0.80, respectively, in the third quarter of 2023[5].

Patent and Regulatory Landscape

INGREZZA is protected by a robust patent portfolio, including 22 patents in the United States and 214 patent family members in 34 countries. However, a generic version of valbenazine tosylate was approved by LUPIN LTD on April 5, 2024, which could potentially impact future market dynamics[4].

Competitive Landscape

The approval of generic versions may introduce competition, but Neurocrine's strong brand presence and ongoing investments in clinical trials and commercial initiatives are expected to maintain INGREZZA's market position. The drug's clinical success in treating tardive dyskinesia and Huntington's disease chorea continues to drive its growth[4].

Clinical Trials and Pipeline

Neurocrine Biosciences is actively expanding its clinical portfolio, including investments in second-generation VMAT2 inhibitors. These efforts are aimed at enhancing the therapeutic options for patients and further solidifying INGREZZA's position in the market[2][5].

Patient Demand and Market Expansion

Strong underlying patient demand has been a key driver of INGREZZA's success. The drug's effectiveness in treating its indicated conditions, coupled with Neurocrine's ongoing commercial initiatives, has led to expanded indications and increased market penetration[2][3].

Financial Projections and Guidance

For 2024, Neurocrine has raised the net product sales guidance for INGREZZA to $2.1-$2.2 billion, reflecting the drug's continued success and the company's confidence in its ability to meet growing patient needs[3][5].

Conclusion

Valbenazine tosylate, under the brand name INGREZZA, has established itself as a leading treatment for tardive dyskinesia and Huntington's disease chorea. The drug's market dynamics are characterized by strong patient demand, significant year-over-year growth, and a robust financial trajectory. Despite the emergence of generic competitors, Neurocrine's strategic investments in R&D and commercial initiatives are poised to maintain INGREZZA's market dominance.

Key Takeaways

• Strong Year-Over-Year Growth: INGREZZA has consistently shown significant year-over-year growth, driven by patient demand and improvements in gross-to-net dynamics.
• Robust Financial Performance: Net product sales have reached billions of dollars, with continued growth projected for 2024.
• Expanding Clinical Portfolio: Neurocrine is investing in second-generation VMAT2 inhibitors and other therapeutic areas to enhance treatment options.
• Competitive Landscape: The approval of generic versions may introduce competition, but Neurocrine's brand strength and ongoing investments are expected to maintain market position.
• Regulatory and Patent Protection: INGREZZA is protected by a substantial patent portfolio, although generic versions have been approved.

FAQs

1. What is the primary mechanism of action of valbenazine tosylate?

   • Valbenazine tosylate works by inhibiting the vesicular monoamine transporter 2 (VMAT2), which is responsible for the transport of monoamines into synaptic vesicles[1].

2. What are the approved indications for INGREZZA?

   • INGREZZA is approved for the treatment of tardive dyskinesia and chorea associated with Huntington's disease[1].

3. How has INGREZZA performed financially in recent years?

   • INGREZZA has shown significant year-over-year growth, with net product sales reaching $1.84 billion in 2023 and projected to be $2.1-$2.2 billion for 2024[3][5].

4. What are the key drivers of INGREZZA's market growth?

   • Strong underlying patient demand, improvements in gross-to-net dynamics, and the drug's clinical success in treating its indicated conditions are the primary drivers of INGREZZA's growth[2][3].

5. Are there any generic versions of INGREZZA available?

   • Yes, a generic version of valbenazine tosylate was approved by LUPIN LTD on April 5, 2024[4].

Sources

1. Synapse - Valbenazine Tosylate - Drug Targets, Indications, Patents.
2. Neurocrine Biosciences - Reports Second Quarter 2024 Financial.
3. Neurocrine Biosciences - Reports Fourth Quarter and Fiscal 2023.
4. DrugPatentWatch - INGREZZA Drug Patent Profile.
5. Neurocrine Biosciences - Reports Third Quarter 2024 Financial.